Investigation on the Cortical Communication (CortiCom) System

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03567213
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgical implantation of CortiCom system — DEVICE
    Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.

Study Details

The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.

Key Dates

Start date
Dec 14, 2021
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Surgical implantation of the CortiCom system

Primary Outcome Measure

Time to device explantation [ Time Frame: 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins MedicineBaltimoreMaryland21205
Nathan E Crone, MD
[email protected]
410-955-6772
Nathan E Crone, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins Medicine· Baltimore, MD

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